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NCT Number: NCT06942598

Feasibility of an ADAPTive Intervention to Improve Food Security and Maternal-Child Health

Food insecurity affects up to 30% of pregnancies and leads to worse health in pregnant people and their children, including an increased risk of gestational diabetes, pre-term birth, and future cardiometabolic chronic conditions (e.g., type 2 diabetes and obesity). Interventions are being utilized to address food insecurity in clinical care settings, but patients differ in the support needed to reduce food insecurity and health systems have limited resources to invest in these interventions. Rather than a single intervention, adaptively allocating interventions could be a more effective, equitable, and efficient approach to improve food security; the objectives of this pilot study are to determine the feasibility of recruiting, retaining, and adaptively providing food insecurity interventions to pregnant patients in anticipation of a large, definitive trial in the future.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The US is facing a maternal and infant health crisis. Each year in the US there are >700 maternal deaths and >60,000 life-threatening pregnancy events. Despite decreasing in other high-income countries, maternal mortality has increased in recent years in the US with a staggering 1210 maternal deaths in 2019. Importantly, maternal deaths in the US are now less likely to be due to direct complications of childbirth, and are increasingly due to endocrine (e.g. gestational diabetes (GDM)) or cardiovascular (e.g. pre-eclampsia) conditions directly related to obesity and other nutrition-related chronic diseases. One significant contributor to maternal mortality is food insecurity (FI), or the lack of consistent access to the food needed for a healthy life. In 2023, 13.5% of US households, (>40 million people), were food insecure. Households with young children have higher rates of FI. Also, up to 30% of pregnancies are impacted by FI. Pregnant and postpartum women are especially vulnerable to the impacts of FI as they have increased nutritional requirements for the growing fetus and while breastfeeding. FI has been associated with inadequate or excessive gestational weight gain, GDM, and pregnancy-induced hypertension. Excess retained weight after pregnancy has important health consequences including development of type 2 diabetes. GDM and gestational weight retention also confer higher risk of complications in subsequent pregnancies and future cardiovascular disease. Additionally, FI is associated with increased risk of preterm birth and infants being born low birth weight, affecting children's growth trajectories and future risk of developing obesity.

To address the high prevalence of FI and its impact on health, national healthcare organizations, including the Centers for Medicare and Medicaid (CMS) and The American College of Obstetricians and Gynecologists, have recommended that health systems address FI as a routine part of clinical care. The integration of interventions to address FI in different populations, particularly those with nutrition-related conditions, has been termed "Food is Medicine". CMS has been piloting Food is Medicine interventions as part of Medicaid reform in several states, including North Carolina. Three "Food is Medicine" interventions that are being studied and used by health systems and insurers include: 1) referring patients to government benefits intended to support nutrition or directly providing food through the use of 2) produce prescriptions and 3) medically-tailored meals. Despite the growing use of FI interventions in clinical care settings, a 2023 systematic review highlighted the need for more research on healthcare system-based interventions to reduce FI in pregnancy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years of age
  • Confirmed viable pregnancy by their obstetrician or midwife based on urine pregnancy test and ultrasound
  • Experience Food Insecurity (FI) based on the 2-item Hunger Vital Sign
  • Speaks English or Spanish
  • Not currently enrolled in WIC
  • First trimester at the time of the initial prenatal visit

Exclusion criteria

  • Planning on moving out of the area within 6 months
  • Severe cognitive impairment or major psychiatric illness that prevents consent or serious medical condition which either limits life expectancy or requires active management (e.g., certain cancers)
  • Lack safe, stable residence or the ability to store the medically tailored meals (MTM)
  • Lack of a telephone
  • Severe food allergy or require a specialized diet (e.g., Celiac)

Treatment and study plan

Produce prescription

Behavioral

Participants randomized to this arm will receive $10 worth of produce delivered to their home weekly. Participants will receive a weekly delivery of produce for 3 months.

Medically tailored meals

Behavioral

Medically tailored meals will be delivered weekly to participant's homes for 3 months. During the 3 months, participants will receive 10 medically-tailored refrigerated or frozen meals (5 lunches and 5 dinners) delivered to their home weekly. All meals are planned by a registered dietician. Meals have minimal preparation time, can be heated by stove, oven, or microwave, and will be provided free-of-charge. Because the meals are medically tailored, participants are asked not to share them. Adherence to meals and food sharing will be measured using food consumption diaries

Electronic health record WIC referral

Behavioral

Participants randomized to this intervention will be referred to their county WIC program through an already developed electronic referral process. To enable WIC offices to receive referrals and easily communicate with healthcare teams, our EHR also offers a community provider-facing, read-only EHR version. We have already successfully provided WIC staff with access and training for our ongoing WIC screening and referral pilot in pediatrics.

Electronic health record WIC referral + care navigation

Behavioral

Participants will receive the same intervention as the electronic WIC referral. In addition, a patient care navigator will meet with the participant at enrollment to discuss any anticipated barriers to accessing WIC. The purpose of the visit is to build rapport and trust and to identify any social and structural barriers to enrolling in WIC. The navigator will also contact participants at 2 weeks to discuss any additional barriers reported and as necessary after the baseline visit. Specific counseling will be tailored based on individual's needs, for example difficulty with paperwork. The navigator will also assess any additional community resources to assist the participant with FI (e.g., local food pantries).

Primary outcomes

  1. Feasibility of recruitment - Proportion of eligible patients who enroll

    Time frame: Baseline

    Proportion of eligible patients who enroll in the study based on study logs

  2. Feasibility of retention - Proportion of eligible participants

    Time frame: Month 6

    The proportion of eligible participants who complete 3-month and 6-month follow-up data collection based on study log

  3. Feasibility of re-randomization - Proportion of eligible participants

    Time frame: Month 3

    The proportion of eligible participants who are re-randomized to a stage 2 intervention based on study log.

  4. Food insecurity Scores

    Time frame: Month 6

    Survey participants using the validated 10-item USDA Adult FSSM, with a 30-day look back period. The tool measures food security over the prior 30 days. Using the standardized scoring provided by the USDA to assess participants responses. This produces a raw score that ranges from 0 to 10 with higher scores indicating worse FI.

    High Food Security: Raw score of 0. Marginal Food Security: Raw score of 1-2. Low Food Security: Raw score of 3-5. Very Low Food Security: Raw score of 6-1

Secondary outcomes

  1. Incidence of Gestational diabetes

    Time frame: Month 6

    Differences in the incidence of gestational diabetes over time based on data extraction from the electronic health record.

  2. Gestational weight gain

    Time frame: Post-delivery

    We will determine the proportion of individuals with excess gestational weight gain. Will be determined by data extraction from the electronic health record and defined as the following: If pre-pregnancy BMI ≥30, gaining ≥20lbs; if BMI 25-29.9, gaining ≥25lbs; if BMI <25, gaining ≥35lbs.

  3. Incidence of Pre-eclampsia

    Time frame: Post-delivery

    Incident number of diagnoses at outpatient, emergency department or hospital encounter based on ICD-10 codes through data extraction from the electronic health record

  4. Number of Community resources uses

    Time frame: month 6

    Change in the number of community resources used (e.g. food pantries, supplemental nutrition assistance program) based on self-report in the study survey.

  5. Infant birth weight at the time of delivery

    Time frame: Baseline

    Infant birth weight at the time of delivery based on data extraction from the electronic health record.

  6. Infant gestational age at the time of delivery

    Time frame: Baseline

    Infant gestational age at the time of delivery based on data extraction from the electronic health record

  7. Post delivery outcomes - Number of vaginal versus c-section Deliveries

    Time frame: Baseline

    Number of Deliveries based on data extraction from the EHR.

  8. Post delivery outcomes - infant APGARS Scores

    Time frame: Baseline

    Infant APGARS, Scores based on data extraction from the EHR. The Apgar score is a quick assessment of a newborn's health, evaluating five key areas: heart rate, respiratory effort, muscle tone, reflex irritability, and skin color. Each area is scored from 0 to 2, with a total score ranging from 0 to 10. A score of 7 or above is considered good, indicating the baby is in generally good health. Lower scores may indicate the need for medical assistance, but do not necessarily predict long-term health problems.

    7-10: Normal, indicating good health and usually requiring only routine post-delivery care.

    4-6: May require some assistance with breathing or other interventions. 0-3: Critical, requiring immediate and potentially life-saving medical attention.

  9. Post delivery outcomes - breastfeeding status

    Time frame: Baseline

    breastfeeding status based on data extraction from the EHR

  10. Number of Glucose homeostasis episodes

    Time frame: Baseline and month 6

    Episodes of hypo- or hyperglycemic episodes based on 14-days continuous glucose monitoring at baseline and 6 months.

Other outcomes

  1. Food expenditures

    Time frame: Month 6

    Report of out-of-pocket monthly expenditures on food based on study survey

  2. Fruit and vegetable intake

    Time frame: Month 6

    Change fruit and vegetable intake over time based on the National Cancer Institute's (NCI) Fruit and Vegetable screener. The NCI Fruit and Vegetable screener measure the frequency and usual portion size for 9 fruit and vegetable components over the prior month.

  3. Depressive symptoms Scores

    Time frame: Month 6

    Change in depressive symptoms over time based on data extraction from the electronic health record. Depressive systems are collected at each OB visit using the validated Patient Health Questionnaire-2 (PHQ-2). Those with a positive PHQ-2 are reflexively assessed using the full PHQ-9. Scores range from 0-27 with higher scores representing a higher number of depressive systems.

  4. Stress Scores

    Time frame: Month 6

    Change in stress based on the Perceived Stress Scale as part of the study survey. Scores range from 0-40 with higher scores representing higher perceived stress.

  5. Healthcare use

    Time frame: Baseline

    Number of missed appointments, emergency department use, and hospitalizations based on data extraction from the EHR.

Study contacts

Contact information is provided by the study sponsor or research team.

Deepak Palakshappa, MD, MSHP

CONTACT

[email protected]

336-716-1795

Rebecca Stone, MPH

CONTACT

[email protected]

336-713-5544

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Feasibility of an ADAPTive Intervention to Improve Food Security and Maternal-Child Health (ADAPT-MCH)

Acronym: ADAPT-MCH

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 24, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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